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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Cont f/u of the premarket HALO Cohort


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General
Study Status Progress Adequate
Application Number P810002 S101/ PAS001
Study Name Cont f/u of the premarket HALO Cohort
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs
Detailed Study Protocol Parameters
Study Design Description The objective of this study is to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm mitral mechanical heart valve as a replacement device for pediatric patients with a diseased, damaged, or malfunctioning mitral valve.



The study includes continued follow-up of patients enrolled in the HALO study, which was a single arm, prospective, non-randomized, multi-center clinical trial of the SJM™ Masters Series Hemodynamic HP 15mm mitral heart valve.



Study Population Description The study population consists of pediatric subjects that are 5 years or less in age with a diseased, damaged, or malfunctioning mitral heart valve.
Sample Size This study will continue to follow subjects that are alive and in which the valve is still implanted from the following groups:

Subjects enrolled in the HALO study,

Subjects enrolled under Continued Access, and

Emergency/compassionate use subjects who have consented for prospective follow-up.

Data Collection The following adverse events (if determined to be valve related and serious) will be summarized annually with descriptive statistics:

Death;

Endocarditis;

Hemorrhage (whether or not due to anticoagulant/antiplatelet medication);

Nonstructural dysfunction (including perivalvular leak, hemolysis, and hemolytic anemia);

Reoperation (including valve explant, not due to anatomical growth of the subject);

Structural valve deterioration;

Thromboembolism; and

Valvular thrombosis.

The following effectiveness endpoints will be reported at any/all time point(s) available:

Mean gradient as assessed by echocardiography;

Peak gradient as assessed by echocardiography; and

Valvular regurgitation grade as assessed by echocardiography.

Follow-up Visits and Length of Follow-up Study subjects will be followed annually either for five years from the date of implant, until subject withdrawal, or until end of device use, whichever occurs earliest.





Cont f/u of the premarket HALO Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/04/2018 09/06/2018 Overdue/Received
one year report 03/06/2019 12/17/2018 On Time
two year report 12/04/2019    
three year report 12/04/2020    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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